BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM ILLU

    MDR report key: 18827050 · Received March 4, 2024

    Report

    Report Number
    1518293-2024-00007
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    January 27, 2024
    Report Date
    February 7, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON ANGIOMAT ILLUMENA INJECTOR PART NUMBER 900006C SERIAL NUMBER (B)(6) ALLEGING AN ERROR "27" AFTER RESTARTING THE DEVICE. FURTHER INFORMATION WAS REQUESTED REGARDING THE FAILURE, AND IT WAS ASCERTAINED THAT THE ERROR WAS PH2027, WHERE THE POWERHEAD DOES NOT RECEIVE THE PIC STATE FROM THE POWER PACK. THERE WAS NO HARM TO THE PATIENT, EVEN THOUGH THE COMPLAINANT INDICATED "SERIOUS INJURY" IN THE INITIAL COMPLAINT DETAILS. THE COMPLAINANT SWITCHED INJECTORS AND COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUE. THIS ALARM OCCURS DURING THE INITIAL POWER UP OF THE INJECTOR AND PRIOR TO PROGRAMMING THE PROCEDURE, PUTS THE INJECTOR INTO A SAFE STATE, UNABLE TO OPERATE. REGIONAL SERVICE TROUBLESHOT THE SYSTEM PER SERVICE MANUAL AND RESOLVED THE ISSUE BY REPLACING THE COMMUNICATION PCB PN 901125-1. THE INJECTOR WAS TESTED FOR PROPER PERFORMANCE AND RETURNED TO CUSTOMER USE. A REVIEW OF CTS SHOWS AN ALARM PP 0013 REPORTED ON THIS UNIT IN AUG 2023 WHERE SERVICE INVESTIGATED ALARM 13 (POWER PACK NEVER ESTABLISHED COMMUNICATION WITH POWERHEAD) AND CLEARED THE ALARM BY REPLACING THE POWER HEAD PCB. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C02, C0201; D02. ROOT / PROBABLE CAUSE CODE: EQUIPMENT/INSTRUMENT - FAILURE. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT REPAIRED AND RETURNED TO SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN WENSHAN, CHINA ON 07 FEBRUARY 2024. INJURY: SERIOUS INJURY INJURY MANIFESTATIONS: AUTOMATIC LAGGING AND CRASH DURING THE PROCEDURE, YELLOW SCREEN AFTER SHUTDOWN AND RESTART, INJECTION HEAD REPORTED ERROR "27", INCREASING THE RISK OF SURGERY. INSTRUMENT FAILURE MANIFESTATIONS: AUTOMATIC LAGGING AND CRASH DURING THE PROCEDURE, YELLOW SCREEN AFTER SHUTDOWN AND RESTART, INJECTION HEAD REPORTED ERROR "27"APPLICATION PROCESS: AUTOMATIC LAGGING AND CRASH DURING THE PROCEDURE, YELLOW SCREEN AFTER SHUTDOWN AND RESTART, INJECTION HEAD REPORTED ERROR "27" EVENT CAUSE ANALYSIS: PRODUCT CAUSE (INCLUDING INSTRUCTIONS, ETC.) EVENT CAUSE ANALYSIS DESCRIPTION:INITIAL HANDLING: REPLACE OTHER EQUIPMENT AND CONTACT THE EQUIPMENT DEPARTMENT FOR EMERGENCY MAINTENANCE.ADDITIONAL INFORMATION RECEIVED ON 08-FEB-2024: - NO ACTUAL HARM TO THE PATIENT UNTIL NOW. THE REPORTER SAID THAT HE CAN'T SURE IF ANY HARM MAY BE FOUND IN THE FUTURE SO HE CHOOSE SERIOUS.- THEY CHANGED ANOTHER INJECTOR AND FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159490 BASE SYSTEM ILLU BASE SYSTEM ILLU DXT LIEBEL-FLARSHEIM 900006C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown